US201 Study: A Phase 2, Randomized Proof-of-Concept Trial of Favipiravir for the Treatment of COVID-19

Background: Favipiravir is used to treat influenza, and studies demonstrate that it has antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Methods: We performed a randomized, open-label, multicenter, phase 2 proof-of-concept trial of favipiravir in hospitalized adult patients with polymerase chain reaction (PCR)-positive coronavirus disease 2019 (COVID-19). Patients were randomized to standard of care (SOC) or favipiravir treatment (1800mg per os twice a day [b.i.d.] on day 1, followed by 1000mg b.i.d. for 13 days). The primary end point was time to viral clearance on day 29. Results: Fifty patients were enrolled and stratified by disease severity (critical disease, severe disease, or mild to moderate disease). Nineteen patients were censored from the event of viral clearance based on being SARS-CoV-2 PCR-negative at the study outset, being PCR-positive at day 29, or because of loss to follow-up. Data from the 31 remaining patients who achieved viral clearance show enhanced viral clearance in the favipiravir group compared with the SOC group by day 29, with 72% of the favipiravir group and 52% of the SOC group being evaluable for viral clearance through day 29. The median time to viral clearance was 16.0 days (90% CI, 12.0 to 29.0) in the favipiravir group and 30.0 days (90% CI, 12.0 to 31.0) in the SOC group. A post hoc analysis revealed an effect in the subgroup of patients who were neutralizing antibody-negative at randomization. Treatment-emergent adverse events were equally distributed between the groups. Conclusions: We demonstrate that favipiravir can be safely administered to hospitalized adults with COVID-19 and believe that further studies are warranted. ClinicalTrialsgov registration: NCT04358549

The COVID-19 vaccination acceptance/hesitancy rate and its determinants among healthcare workers of 91 Countries: A multicenter cross-sectional study.

The aim of this study was to investigate the COVID-19 vaccination acceptance rate and its determinants among healthcare workers in a multicenter study. This was a cross-sectional multi-center survey conducted from February 5 to April 29, 2021. The questionnaire consisted of 26 items in 6 subscales. The English version of the questionnaire was translated into seven languages and distributed through Google Forms using snowball sampling; a colleague in each country was responsible for the forward and backward translation, and also the distribution of the questionnaire. A forward stepwise logistic regression was utilized to explore the variables and questionnaire factors tied to the intention to COVID-19 vaccination. 4630 participants from 91 countries completed the questionnaire. According to the United Nations Development Program 2020, 43.6 % of participants were from low Human Development Index (HDI) regions, 48.3 % high and very high, and 8.1 % from medium. The overall vaccination hesitancy rate was 37 %. Three out of six factors of the questionnaire were significantly related to intention to the vaccination. While 'Perceived benefits of the COVID-19 vaccination' (OR: 3.82, p-value<0.001) and 'Prosocial norms' (OR: 5.18, p-value<0.001) were associated with vaccination acceptance, 'The vaccine safety/cost concerns' with OR: 3.52, p-value<0.001 was tied to vaccination hesitancy. Medical doctors and pharmacists were more willing to take the vaccine in comparison to others. Importantly, HDI with OR: 12.28, 95 % CI: 6.10-24.72 was a strong positive determinant of COVID-19 vaccination acceptance. This study highlighted the vaccination hesitancy rate of 37 % in our sample among HCWs. Increasing awareness regarding vaccination benefits, confronting the misinformation, and strengthening the prosocial norms would be the primary domains for maximizing the vaccination coverage. The study also showed that the HDI is strongly associated with the vaccination acceptance/hesitancy, in a way that those living in low HDI contexts are more hesitant to receive the vaccine

Sporotrichoid Skin Infection Caused by Nocardia brasiliensis in a Kidney Transplant Patient

Prompt and accurate diagnosis of Nocardia skin infections is important in immunocompromised hosts, especially transplant patients. The sporotrichoid form, which is otherwise known as the lymphocutaneous form of Nocardia skin involvement, can mimic other conditions, including those caused by fungi, mycobacteria, spirochetes, parasites and other bacteria. Delayed or inaccurate diagnosis and treatment of Nocardia skin infections in transplant patients could lead to dissemination of disease and other poor outcomes. Nocardia brasiliensis is a rare cause of lymphocutaneous nocardiosis in solid organ transplant patients with only two other cases reported to our knowledge. This case describes a middle-aged man, who presented 16 years post kidney transplant. He developed a sporotrichoid lesion on his upper extremity one week after gardening. Ultrasound showed a 35-cm abscess tract on his forearm, which was subsequently drained. Nocardia brasiliensis was isolated from pus culture and he was treated successfully with amoxicillin/clavulanate for 6 months. A review of the relevant literature is included

947. Stroke demographics and risk factor profile in HIV infected individuals in Florida

Abstract Background The risk of ischemic stroke (IS) is known to be higher in people living with HIV (PLWH) than uninfected controls. However, information about the demographics and risk factors for hemorrhagic stroke (HS) in PLWH is scant. Specifically, very little is known about the differences in the stroke risk factors between HS and IS in PLWH. The goal of this study was to determine the demographics and risk factor differences between HS and IS in PLWH. Methods We retrospectively analyzed the demographic and clinical data of PLWH in OneFlorida (1FL) Clinical Research Consortium from October 2015 to December 2018. 1FL is a large statewide clinical research network and database which contains health information of over 15 million patients, 1240 clinical practices, and 22 hospitals. We compared HS and IS based on documented ICD 9 and 10 diagnostic codes and extracted information about sociodemographic data, traditional stroke risk factors, Charlson comorbidity scores, habits, HIV factors, diagnostic modalities and medications. Statistical significance was determined using 2-sample T-test for continuous variables and adjusted Pearson chi square for categorical variables. Odds ratio (OR) and 95% confidence intervals (CI) between groups were compared. Results Overall, from 1FL sample of 13986 people living with HIV, 574 subjects had strokes during the study period. The rate of any stroke was 18.2/1000 person-years (PYRS). The rate of IS was 10.8/1000 PYRS while the rate of HS was 3.7/1000 PYRS, corresponding to 25.4% HS of all strokes in the study. Table 1 summarizes the pertinent demographic and risk factors for HS and IS in PLWH in the study. Table 1: Summary of pertinent demographic and risk factors for hemorrhagic and ischemic strokes in people living with HIV from One Florida database Conclusion In this large Floridian health database, demographics and risk factor profile differs between HS and IS in PLWH. Younger age group is associated with HS than IS. However, hypertension, hyperlipidemia and coronary artery disease are more likely to contribute to IS than HS in PLWH. Further research is needed to better understand the interplay between known and yet unidentified risk factors that may be contributing to HS and IS in PLWH. Disclosures All Authors: No reported disclosure

A case of Mycobacterium fortuitum prosthetic joint infection successfully treated medically without prosthesis explantation or joint debridement

A 58-year-old man with a history of end-stage degenerative joint disease developed a postsurgical infection at the right hip 4 weeks after hip replacement surgery. He underwent surgical washout of the right hip without opening the joint capsule. Arthrocentesis returned positive for Mycobacterium fortuitum. He was started on antibiotics with the recommendation to remove the prosthesis. The prosthesis was retained. Based on antimicrobial susceptibilities, he was treated with 4 weeks of intravenous therapy using cefoxitin and amikacin and later switched to oral ciprofloxacin and doxycycline for 5 additional months. Eighteen months from his initial hip replacement surgery, he continues to do well. Joint aspiration culture is important to make a diagnosis of prosthetic joint infection (PJI) when periprosthetic culture is not available. In the absence of serious systemic or comorbid joint conditions, PJI due to M. fortuitum can be managed medically without having to remove the prosthesis or debride the joint

Clinical Outcomes of Prosthetic Knee Joint Infection in a United States Tertiary Healthcare Center

Abstract Background The 2013 IDSA prosthetic joint infection (PJI) guidelines identified some research gaps, some of which include what factors may predict PJI outcome. We therefore conducted a retrospective single-center study with the goal of addressing some of these gaps. Objectives 1. Describe the incidence, pathogens, role of inflammatory markers, and treatment outcomes of knee PJI. 2. Identify correlations between joint aspiration (JA) and intraoperative (IO) cultures. Methods We retrospectively analyzed all adult knee PJI that were diagnosed and managed at our institution between 1/1/2005 and 12/31/2015. Statistical analysis was done using the paired t-test, Fisher exact and McNemar χ 2 tests as applicable. Results Forty-six subjects met the inclusion criteria and were analyzed. See table below. The incidence rate of PJI for the study period was 5.4%.. Staph. aureus was the commonest pathogen accounting for 11(65%) JA and 13(40%) of IO cultures. Low virulence organisms [Staph. epidermidis n = 8 (25%) and Corynebacterium spp. n =1 (3%)] were only recovered from IO cultures. Gram-negative bacilli accounted for 5(30%) JA and 7(28%) IO cultures.. JA correlates well with IO cultures using paired sample correlations (t-test); (correlation 0.61, P = 0.027).. 97% of subjects had elevated ESR while 96% had elevated CRP.. Concerning outcome, there was no statistically significant difference between groups based on implant duration (P = 0.98), symptom onset (P = 0.23), pathogen type (P = 0.83), and treatment options (P = 0.39). Conclusion 1. JA culture is a good predictor of IO culture in knee PJI. 2. Yield of low virulence organisms from JA culture is poor. 3. Elevated ESR and CRP can support diagnosis of knee PJI. 4. Implant duration, pathogen type, duration of symptoms and treatment type do not appear to affect outcome. Disclosures All authors: No reported disclosures

“Holes” in the Jaw—A Report of Two Cases of Periapical Actinomycosis

Periapical actinomycosis is a relatively rare form of cervicofacial actinomycosis, which typically involves the periapical region with subsequent potential spread to the jaw bones. We hereby present two cases of periapical actinomycosis. Both patients presented with jaw pain and &ldquo;holes&rdquo; in their gum and lacked the characteristic clinical features commonly seen in cervicofacial actinomycosis such as jaw mass, draining ulcers, sinuses and fistulae. The first patient was an immunocompetent host with chronic stable medical conditions but with a rather bad dentition requiring multiple recent teeth extractions. The second patient was edentulous, had refractory multiple myeloma, was on low-dose chronic steroids and pomalidomide therapy and therefore relatively immunocompromised. Both cases of actinomycosis were diagnosed by jaw bone histopathology, which showed characteristic sulfur granules and embedded Actinomyces-like organisms. The two patients had excellent clinical response to six months of penicillin therapy without any need for surgical intervention. The cases remind clinicians of including actinomycosis in the differential diagnosis of periapical lesions and illustrates the possibility of achieving cure with non-surgical treatment